Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

Not Applicable

Not yet recruiting

• Conditions: Induction of Labor
• Interventions: Device: cervical ripening balloon for twelve hours; Device: cervical ripening balloon for one hour

• Registration Number: NCT05922111
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery.

Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.

Detailed Description

The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours.

Study Protocol:

1. Women planned for induction of labor will be approached by a trained resident and will sign informed consent.

2. All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes.

3. Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC).

4. Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician

Study Timeline

• Study First Submitted: 2022-11-27
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-18
• Last Update Submitted: 2023-06-18
• Study First Posted: 2023-06-28
• Last Update Posted: 2023-06-28
• Study Start: 2023-08-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 164

Inclusion Criteria

1. Nulliparous or multiparous gravidas
2. Gestational age ≥ 370/7 to 416/7 gestational weeks
3. Age 18-45
4. Signed informed consent

Exclusion Criteria

1. Contraindications for vaginal delivery
2. Multifetal gestation
3. Rupture of membranes
4. Bishop score > 6
5. The cervix is dilated to more than 2 cm
6. Previous caesarean delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cervical ripening balloon for 12 hours	cervical ripening balloon for twelve hours	Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after 12 hours in the control group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician
cervical ripening balloon for 1 hour	cervical ripening balloon for one hour	Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician

Primary Outcome Measures

Name	Time	Method
insertion to delivery time interval	From date of balloon insertion until the date of delivery, assessed up to 4 days	The time interval between balloon insertion to delivery

Secondary Outcome Measures

Name	Time	Method
to compare the rate of anal sphincter injuries	From date of balloon insertion until the date of discharge, assessed up to 8 days	Rate of obstetric anal sphincter injuries
to compare the mode of delivery	From date of balloon insertion until the date of delivery, assessed up to 4 days	Mode of delivery
to compare the rate of chorioamnionitis	From date of balloon insertion until the date of discharge, assessed up to 8 days	Rate of chorioamnionitis
to compare the need for blood transfusion	From date of balloon insertion until the date of discharge, assessed up to 8 days	the need for blood transfusion
To compare the length of maternal hospital stay	From date of balloon insertion until the date of discharge, assessed up to 8 days	Length of maternal hospital stay
to compare the time to active and second stage of labor	From date of balloon insertion until the date of delivery, assessed up to 4 days	Time to active and second stage of labor
to compare the rate of post-partum hemorrhage	From date of balloon insertion until the date of discharge, assessed up to 8 days	Rate of post-partum hemorrhage and need for blood transfusion
To compare the rate of neonatal acidemia between the groups	From date of delivery until the date of neonate discharge, assessed up to 14 days	Neonatal acidemia
To compare the overall satisfaction rate	From date of balloon insertion until the date of discharge, assessed up to 8 days	Overall satisfaction using the Birth satisfaction scale questionnaire with higher score means a better outcome. minimal score 30, maximal score 150.
To compare the Apgar score between the groups	at the date of delivery	Apgar score - higher score means better outcome. Minimal score is 0, maximal Apgar score is 10.
To compare the rate of admission to neonatal intensive care unit between the groups	From date of delivery until the date of neonate discharge, assessed up to 14 days	Admission to neonatal intensive care unit
To compare the rate of Respiratory complications between the groups	From date of delivery until the date of neonate discharge, assessed up to 14 days	Respiratory complications
To compare the rate of neonatal sepsis between the groups	From date of delivery until the date of neonate discharge, assessed up to 14 days	Neonatal sepsis
To compare the rate of birthweightbetween the groups	at the date of delivery	Birthweight in grams